Clinical Characteristics and Real-World Outcomes of Chinese Patients With Hypertrophic Cardiomyopathy: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- Composite Cardiovascular Endpoints
研究概览
简要总结
This study is a prospective cohort study aimed at exploring the baseline characteristics and treatment patterns of the Chinese population with hypertrophic cardiomyopathy (HCM) in real-world settings. The objective is to assess the real-world treatment approaches and longitudinal outcomes in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent (ICF) and any required privacy authorization before the start of the study.
- •Aged ≥18 years at the time of signing the written informed consent.
- •Diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, meeting the following criteria:
- •Left ventricular wall thickness ≥15 mm in any segment at end-diastole, as assessed by echocardiography or cardiac magnetic resonance imaging (MRI).
- •Left ventricular wall thickness ≥13 mm in individuals with a positive pathogenic gene test or those identified as members of a genetically affected family.
- •Exclusion of other cardiovascular diseases or systemic/metabolic diseases causing ventricular wall thickening.
排除标准
- •Uncontrolled primary hypertension.
- •Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation.
- •Confirmed infiltrative or storage diseases with a phenotype resembling hypertrophic cardiomyopathy (e.g., Fabry disease, amyloidosis).
- •Expected life expectancy <1 years.
- •Severe infections, liver failure, renal failure, or other life-threatening conditions.
研究组 & 干预措施
HCM
Patients diagnosed with hypertrophic cardiomyopathy (HCM) according to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy were consecutively enrolled. These patients received pharmacological, interventional, or surgical treatment based on real-world treatment strategies. Follow-up was conducted to observe patient prognosis and the occurrence of outcome events.
干预措施: No interventions were applied to the patients. (Other)
结局指标
主要结局
Composite Cardiovascular Endpoints
时间窗: 5 years
Number of Participants with a composite cardiovascular endpoint consisting of ischemic stroke, heart failure hospitalization, and cardiovascular death
次要结局
- All-cause mortality(5 years)
- Cardiovascular death(5 years)
- New-onset arrhythmia(5 years)
- Sudden cardiac death (SCD)(5 years)
- Non-fatal acute myocardial infarction(5 years)
- Ischemic stroke(5 years)
- Heart failure hospitalization(5 years)
- New York Heart Association (NYHA) Classification(5 years)
- Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)(5 years)
- BNP/NT-proBNP(5 years)
- Troponin T/I(5 years)